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Trial registered on ANZCTR


Registration number
ACTRN12614000781640
Ethics application status
Approved
Date submitted
3/07/2014
Date registered
21/07/2014
Date last updated
21/07/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A proof-of-concept study to assess the effect of ACT-451840 against early Plasmodium falciparum blood stage infection in healthy subjects.

Scientific title
A proof-of-concept study to assess the effect of ACT-451840 against early Plasmodium falciparum blood stage infection in healthy subjects
Secondary ID [1] 284915 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 292385 0
Condition category
Condition code
Infection 292700 292700 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Drug Description:
Dosage: 500 mg of ACT-451840
Mode of Administration: Oral Suspension
Frequency and Duration: Single dose

Strategies to monitor adherence:
Oral suspension shall be administered in the presence of the investigational site team.

Parasite introduction
Type of parasite/ dose: malaria inoculum of ~1,800 viable Plasmodium falciparum-infected human erythrocytes
Administration: Intravenously
Administration time: approximately 7 days prior to ACT-451840 administration.

Intervention code [1] 289735 0
Treatment: Drugs
Comparator / control treatment
There is no control group. All subjects shall be administered with the malaria inoculum and all will receive ACT-451840 treatment.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292543 0
To characterize the anti-malarial activity of ACT-451840 administered orally on clearance of Plasmodium falciparum blood stage parasites from the blood in healthy subjects.

Activities to be measured are antimalarial activity of ACT-451840 through bioassay;
Timepoint [1] 292543 0
up to 16 days after administration of ACT-451840.
Secondary outcome [1] 309190 0
To characterize the pharmacokinetics of ACT-451840 in the challenge model - introduction of Plasmodium falciparum blood stage parasites in healthy subjects.

Outcome shall be assessed pharmacokinetics sampling.
Timepoint [1] 309190 0
144 hours post dose
Secondary outcome [2] 309191 0
To assess the tolerability of ACT-451840 in the challenge model - vital signs (temperature, heart rate, blood pressure and respiratory rate), hematology, biochemistry and liver functin test, urinalysis, adverse event monitoring.
Timepoint [2] 309191 0
Up to 31 days after introduction of the Plasmodium falciparum blood stage parasites.
Secondary outcome [3] 309192 0
To investigate ex vivo / in vitro antimalarial activity of ACT-451840 (bioassay)
Timepoint [3] 309192 0
144 hours post dose

Eligibility
Key inclusion criteria
Healthy volunteers
Minimum age
18 Years
Maximum age
50 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any history of malaria.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2699 0
Q-Pharm Pty Limited
Recruitment postcode(s) [1] 8411 0
4006 - Herston

Funding & Sponsors
Funding source category [1] 289539 0
Commercial sector/Industry
Name [1] 289539 0
Actelion Pharmaceuticals Australia Pty.
Address [1] 289539 0
Suite 6
13B Narabang Way
Belrose NSW 2085
Country [1] 289539 0
Australia
Primary sponsor type
Individual
Name
James McCarthy
Address
Q-Pharm Pty Limited
Level 5, 300C Herston Road
Herston QLD 4006, Australia
Country
Australia
Secondary sponsor category [1] 288225 0
None
Name [1] 288225 0
Address [1] 288225 0
Country [1] 288225 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291280 0
The Queensland Institute of Medical Research
Ethics committee address [1] 291280 0
300 Herston Rd, Brisbane QLD 4006

Ethics committee country [1] 291280 0
Australia
Date submitted for ethics approval [1] 291280 0
Approval date [1] 291280 0
14/03/2014
Ethics approval number [1] 291280 0
P2049

Summary
Brief summary
A proof-of-concept study to assess the effect of ACT-451840 against early Plasmodium falciparum blood stage infection in healthy subjects
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49670 0
Prof James McCarthy
Address 49670 0
Q-Pharm Pty Limited
Level 5, 300C Herston Road,
Herston, QLD 4006
Country 49670 0
Australia
Phone 49670 0
+61 07 3845 3636
Fax 49670 0
Email 49670 0
j.mccarthy@uq.edu.au
Contact person for public queries
Name 49671 0
Prof James McCarthy
Address 49671 0
Q-Pharm Pty Limited
Level 5, 300C Herston Road,
Herston, QLD 4006
Country 49671 0
Australia
Phone 49671 0
+61 07 3845 3636
Fax 49671 0
Email 49671 0
j.mccarthy@uq.edu.au
Contact person for scientific queries
Name 49672 0
Prof James McCarthy
Address 49672 0
Q-Pharm Pty Limited
Level 5, 300C Herston Road,
Herston, QLD 4006
Country 49672 0
Australia
Phone 49672 0
+61 07 3845 3636
Fax 49672 0
Email 49672 0
j.mccarthy@uq.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary